QA Associate, Aseptic Operations
Pharmaceutics International Inc Cockeysville, MD
- Expired: over a month ago. Applications are no longer accepted.
Are you ready to join our mission to develop and manufacture quality drug products? Do you have a passion for improving the health and well-being of mankind by empowering cutting-edge science, knowledge-sharing, and the unwavering pursuit of ‘excellence.’? Come be part of the Pii team where every day we challenge frame opportunities!
Since 1999, Pii has grown from 12 to over 225 employees, and over 210,000 square feet of space in the U.S! The power of Pii is the art and science of enabling multiple operations to occur simultaneously in time and space to achieve extraordinary outcomes!
But we can’t do it without YOU!
To help us meet our goals we are looking to hire a QA Associate, Aseptic Operations to join our family.
If any of the below describes you, we would love to speak with you!
In this role you will be responsible for:
- Witness and verify the QA functions related to manufacturing of sterile product while adhering to the cGMP ICH and USP/EP/Health Canada guidelines as written -- to ensure that the day-to-day tasks of the Quality Assurance Unit supports the overall business plan while maintaining the highest quality products and ensuring the safety, identity, strength, purity, and quality that the drug is purported to possess.
- Perform “Line Clearance” and “Cleaning Verification” for manufacturing and packaging operations per established Standard Operating Procedures (SOPs) and Batch/Packaging and Labeling Records’ requirements.
- Perform in-process sampling, inspections, testing, and batch record reviews during manufacturing and packaging operations as per established SOPs and Batch/Packaging and Labeling Records’ requirements.
- Perform Acceptable Quality Level (AQL) sampling for in-process and finished product.
- Participate in the preparation for sampling, actual submission of samples to Quality Control (QC) and Micro lab, and disposition of samples for Cleaning Verification.
- Perform inspection of cGMP areas for compliance to policies and procedures as written approved.
- Perform daily systems verifications including, but not limited to, recording and reporting of magnehelic gauge data and water system data and the disposition of the systems.
- Perform investigational activities and prepare Incident Reports, Investigation Reports, change controls as assigned.
- Understand quality systems, including policies and procedures, and recommend improvements affecting compliance and efficiencies.
- Perform Master and Batch Production Records Review (Aseptic Manufacturing)
- Help in review of validation protocols, raw data and reports.
- Able to support above mentioned activities in both shifts as required.
- Other duties as assigned.
To be successful in this role, your background and experience should include:
- A background in cGMP compliance or operations within the pharmaceutical, biologics or medical device manufacturing industry is required. Must have bachelor’s degree in Microbiology or Chemistry.
- At least one (1) to three (3) years of experience in a quality assurance role in a cGMP-regulated environment. Prior aseptic manufacturing experience is preferred.
- Must be able to perform task in Class100 area with sterile gowning requirements.
- Experience in reviewing, writing and maintaining cGMP documentation.
- Ability to analyze data/information and to assess and resolve complex issues, as required.
- Good verbal and written communication skills.
- Ability to work in both shifts and communicate with cross-functional teams.
- Strong prioritization, communication, and organizational skills.
- Ability to multi-task, manage multiple priorities and re-prioritize tasks, as required.
- Ability to train other individuals effectively in programs and procedures.
What can Pii offer you? (Besides an amazing and innovative culture?)
- All Inclusive - Full Benefits Package
- PTO Package
- Company Social Events
- Team Member Assistance Program
- Professional Support & Development
Pharmaceutics International, Inc. (“Pii") is proud to be an Equal Opportunity Employer, including supporting applicants and employees with a disability or protected veterans, as well as any other status protected by law.
Pharmaceutics International Inc
TechnologyView all jobs at Pharmaceutics International Inc